Use and persistence of single and multiple inhaler triple therapy prescribed for patients with COPD in France: a retrospective study on THIN database (OPTI study).

INTRODUCTION: From 2018 single inhaler triple therapy (SITT) became available in France to treat moderate-to-severe chronic obstructive pulmonary disease (COPD). Given its simplified inhaler use compared with multiple inhaler triple therapy (MITT), this therapeutic option has the potential to offer benefit in terms of improved persistence and adherence. Given the lack of real-world evidence of the effectiveness of triple therapy, this study was designed to evaluate the use of MITT and SITT in France and compare persistence. METHODS: A retrospective cohort study was performed. Patients with COPD who initiated triple therapy between 1 July 2017 and 31 December 2019 were included from The Health Improvement Network, a large electronic medical database in France, which includes pharmacy data. A 60-day treatment gap defined discontinuation and thereby persistence. RESULTS: A total of 3134 patients initiated triple therapy for COPD in the study period, among them 485 with SITT. In 2019, the rate of use of SITT was 28.2%. The mean age (67.3 years) and sex (44.2% female) of patients initiating triple therapy was similar between MITT and SITT, and most patients had escalated from dual therapy (84.1%). However, SITT was more frequently initiated by a pulmonologist (59.8%) and a higher prevalence of comorbid asthma was observed for SITT (47.0% vs 37.9%). Persistence was assessed among patients who did not discontinue after a single dispensation of triple therapy (n=1674). Median persistence was 181 days for SITT and 135 days for MITT, and the covariate-adjusted HR for persistence was 1.47 (p<0.001) and the estimated persistence at 1 year was 33% for SITT compared with 18% for MITT. DISCUSSION: This study suggests that persistence was higher for the patients treated with SITT compared with MITT in France. Moreover, most patients initiated with triple therapy were previously treated with dual therapy and had exacerbations in the previous year.

Characteristics of Severe Non-Eosinophilic Asthma: Analysis of Data from 1075 Patients Included in the FASE-CPHG Study.

Purpose: Data on severe non-eosinophilic asthma are scarce. Moreover, as compared with eosinophilic asthma, non-eosinophilic asthma less frequently benefits from the latest therapeutic advances. This study aimed to highlight differences between non-eosinophilic and eosinophilic asthma as they may help the development of new therapeutic agents. Patients and Methods: Data from 1075 adult patients with severe asthma (GINA treatment: 4/5) collected during the cross-sectional non-interventional FASE-CPHG study were analyzed. Two groups of patients (EOS-/EOS+) were constituted based on blood eosinophil counts (cutoff value: 300 G/l). Characteristics of EOS- (N = 500) and EOS+ (N = 575) patients were described; EOS- patients were also described according to their allergic profile based on skin allergy or allergen-specific immunoglobulin E (IgE) assays (cutoff value: 150 IU/mL). Results: Percentages of patients with obesity (29%), allergen sensitization (57%), or ≥2 annual exacerbations in the last 12 months (68%) were similar in both groups. As compared with EOS+ patients, EOS- patients less frequently reported chronic rhinitis (41.1% vs 50.5%, p < 0.01) or nasal polyposis (13.6% vs 27.5%, p < 0.01), and more frequently reported GERD (45.2% vs 37.1%, p < 0.01), anxiety (45.5% vs 38.1%, p = 0.01), or depression (18.3% vs 13.3%, p = 0.02). EOS- patients had lower serum total IgE levels (median: 158 vs 319 IU/mL, p < 0.01) and were less frequently treated with long-term oral corticosteroid therapy (16.0% vs 23.7%; p < 0.01). Their asthma was more frequently uncontrolled (48% vs 40%, p < 0.01). Similar results were found with a cutoff value for blood eosinophil counts at 150 G/l. EOS- patients with allergic profile less frequently reported high serum IgE levels (35.6% vs 57.9%, p < 0.01). EOS- and EOS+ patients treated with long-term oral corticosteroids had similar profiles. Conclusion: In our patients with severe asthma, EOS- asthma was approximately as frequent as EOS+ asthma; EOS- asthma was frequently poorly controlled or uncontrolled, confirming the need for a better management. Allergy did not appear to worsen clinical profile.

Asthma burden according to treatment steps in the French population-based cohort CONSTANCES.

BACKGROUND: Data on health care consumption and costs of asthma in the French population are scarce. OBJECTIVES: The study objective was to describe the burden of asthma according to GINA treatment steps in the CONSTANCES cohort. METHODS: Data from 162,725 participants included between 2012 and 2019 were extracted. Participants were considered as current asthmatics if asthma was reported at inclusion and asthma symptoms and/or treatments were reported in 2019. Participants were classified in three categories according to GINA treatment steps. The results were compared to non-asthmatic participants matched with a propensity score calculated on age, sex, region of residence, precariousness score and year of inclusion. RESULTS: Among 162,725 participants aged 18-69 years, 6783 asthmatics (1566 not treated for asthma, 2444 + 251 GINA steps 1 + 2, 1054 + 1315 GINA steps 3 + 4, and 153 GINA step 5) were matched with 6783 controls. Average annual ambulatory cost and average annual hospitalization cost were respectively €1925 and €719 for asthmatics versus €1376 and €511 for participants without asthma (p < 0,0001). Cardiovascular risk factors, co-morbidities, visits and hospitalizations were higher for asthma participants as compared to controls and increased with GINA steps, as well as inpatient and outpatient costs. However, for cardiovascular risk factors and co-morbidities, differences were non-significant in multivariate analyses. Pharmacy costs were ten times higher for GINA step 5 participants than for GINA steps 1-2 participants: €3187 versus €393 (p < 0,0001). CONCLUSION: mean cost of asthma was estimated at €757 per patient/year and increased with GINA treatment step.

Self-reported asthma prevalence and management in adults in France in 2018: ASTHMAPOP survey.

BACKGROUND: There is a paucity of epidemiological data on asthma classified by disease severity in France. The ASTHMAPOP cross-sectional study aimed to review the prevalence and current management of asthma in people aged ≥18 years in France. METHODS: A self-administered questionnaire was mailed to 19 676 people representative of the French population in age, gender, region, and socio-economic status. Asthma was classified by treatment steps per the 2017 Global Initiative for Asthma (GINA) report, according to prescribed treatments. Analyses were mostly descriptive. RESULTS: The questionnaire return rate was 81.7% (n = 16 083), and 15 587 questionnaires were analyzed. The prevalence of lifetime asthma was 12.8% (95% confidence interval (CI):12.3-13.3%; n = 1 989) in 2018. The prevalence of current asthma (i.e., 12 months before the survey) was 6.4% (95% CI: 6.0-6.8%; n = 993); most of these respondents (95.3% [n = 946]) were receiving asthma treatment, and 49.4% (n = 491) were treated for mild asthma (GINA step 1 or 2). Of people with current asthma, 47.6% reported ≥1 asthma exacerbation in the past 12 months-defined as episodes (several days) during which symptoms (cough, sputum, and dyspnea) were worse than usual; 14.3% had ≥1 emergency visit, and 3.1% had ≥1 hospitalization due to asthma. Of those taking continuous asthma controller medications who answered all Morisky Medication Adherence Scale questions (n = 501), 46.4% were adherent (score=4) to their treatment regimen. Based on the 6-item Asthma Control Questionnaire scores, asthma was partially controlled or uncontrolled in 47.7% of 969 people. CONCLUSIONS: The prevalence of asthma in France has remained stable since 2006, but levels of asthma control and treatment adherence continue to be relatively poor. Asthma management in France requires improvement.

Perception of oral corticosteroids in adult patients with asthma in France.

OBJECTIVE: Oral corticosteroids (OCS) are frequently used as relievers for acute asthma and controllers for severe asthma. However, the relief offered by OCS is counterbalanced by adverse effects. We aimed to describe how patients perceive OCS treatment benefits and risks, and how this could affect their adherence to the treatment. METHODS: Patients aged ≥18 years with asthma registered with Carenity, an online patient community, were invited to respond to a questionnaire containing 35 closed and 3 open questions to assess their asthma and perceptions of OCS. RESULTS: 268/300 respondents were receiving or had received OCS for asthma (58 for long-term use and 107 for short-term use). The mean age at diagnosis was 21.3 years. 66% had uncontrolled asthma (GINA control score 3 or 4). Although 42% perceived OCS to be efficacious, 46% mentioned adverse effects. Respondents were mostly satisfied with OCS (median = 7.0/10), particularly for efficacy (median = 8.0/10). Respondents reported having strategies to avoid OCS, mainly because of adverse effects. 26% of respondents had previously reduced or stopped OCS; this proportion was 22% for short-term OCS users and 36% for long-term users. 15% of the respondents not receiving long-term OCS would take the treatment without doing anything else if long-term OCS were prescribed; 42% would seek an alternative treatment. CONCLUSIONS: OCS for asthma is perceived efficient but associated with adverse effects. Patients seek alternative treatment.

The Burden of Severe Asthma in France: A Case-Control Study Using a Medical Claims Database.

BACKGROUND: Severe asthma (SA) is defined by treatment intensity. The availability of national databases allows accurate estimation of the prevalence, long-term outcomes, and costs of SA. OBJECTIVE: To provide accurate information on SA, focusing on comorbidities, mortality, health care resource consumption, and associated costs. METHODS: A cohort of patients with SA identified in 2012 was extracted from a French representative claims database and followed for 3 years. Their characteristics, comorbidities, mortality, and direct costs were compared with a matched control group without asthma. RESULTS: A total of 690 patients with SA were matched to 2070 patients without asthma (mean age, 61 years; 65.7% women). The prevalence of SA was estimated to be 0.18% to 0.51% of the French adult population. Comorbidities were more frequent in patients with SA (73.9% suffered from cardiovascular disease vs 54.3% in controls; P < .001). A total of 58.7% of patients with SA used oral corticosteroids (OCS) in 2012 with a mean intake of 3.3 boxes/year/patient and 9% received ≥6 dispensings of OCS. A total of 6.7% were treated by omalizumab. Patients with SA were more frequently hospitalized (33.2% vs 19.7%; P < .001), more frequently consulted a general practitioner (97.8% vs 83.9%; P < .001) (9.8 ± 6.8 vs 6.2 ± 5.3 consultations/year; P < .001), and 31% have consulted a private respiratory physician. Compared with controls, 3-year cumulative mortality was higher in SA (7.1% vs 4.5%; P = .007). Direct medical cost was $9227 versus $3950 (P < .001) mostly driven by medication costs. CONCLUSIONS: The prevalence of SA in the French adult population is at least 18 of 10,000. Burden of disease is high with respect to comorbidities, mortality, and asthma-related health care resource use.

Characteristics of patients with severe, uncontrolled, eosinophilic asthma enrolled in a French cohort.

BACKGROUND AND OBJECTIVE: Benralizumab (Fasenra™) has recently been approved as add-on maintenance treatment for adult patients with severe eosinophilic asthma inadequately controlled despite high-dosage inhaled corticosteroids plus long-acting ß2-agonists. We aimed to identify and describe the clinical characteristics and disease burden of patients with severe, uncontrolled, eosinophilic asthma in France who may be eligible for treatment with benralizumab. PATIENTS AND METHODS: This was a retrospective analysis of a prospective, noninterventional, observational study of patients in France enrolled in the Asthma and Bronchial Obstruction Cohort (COBRA). First, we selected adult patients with severe asthma, a documented blood eosinophil count, 12 months of baseline data, and 12 months of follow-up data. Of these study-eligible patients, we next determined the prevalence and described the clinical characteristics and disease burden of patients who would be eligible to receive benralizumab, namely those with ≥2 asthma exacerbations in the previous 12 months and a blood eosinophil count ≥300/µL who were receiving high-dosage inhaled corticosteroids/long-acting ß2-agonists. RESULTS: Of the 441 patients eligible for this study, 85 (19%) met the criteria for benralizumab therapy. At study inclusion, benralizumab-eligible patients had a smaller prebronchodilator forced expiratory volume in 1 second and less effective asthma control compared with benralizumab-ineligible patients. During the 12-month follow-up period, benralizumab-eligible patients had greater frequencies of asthma exacerbations and hospitalizations compared with benralizumab-ineligible patients. CONCLUSION: Of patients with severe asthma, approximately 20% were qualified for benralizumab treatment. Benralizumab-eligible patients had increased bronchial obstruction, worse asthma control, and a greater frequency of asthma exacerbations and hospitalizations during follow-up care compared with benralizumab-ineligible patients, demonstrating inadequate disease control for these patients.